In standard surgical practice, access to cardiac valves and internal cardiac structures is achieved with the use of cardiopulmonary bypass cardiac arrest and incision into the arrested heart or aorta. Using currently available technology, all cardiac valvular operations require such an approach.
It is well-known that cardiopulmonary bypass and cardiac arrest are associated with significant morbidity and mortality. Recognition of the damaging effects of cardiopulmonary bypass has been the impetus for important advances in beating heart coronary artery bypass grafting. To date, however, it is believed that there are no clinically applicable techniques to perform cardiac valve surgery without using a heart-lung machine. Therefore, cardiac valve surgery currently requires a major operation that includes all of the complications attributable to cardiopulmonary bypass.
In prior U.S. Provisional Patent Application Ser. Nos. 60/117,599, filed on 27 Jan. 1999, 60/152,135, filed on 25 Aug. 1999, 60/161,934, filed on 28 Oct. 1999, 60/215,542, filed on 30 Jun. 2000, and 60/230,756, filed on 7 Sep. 2000, and in pending PCT Patent Application No. PCT/US00/02126, filed on 27 Jan. 2000, which patent applications are hereby incorporated herein by reference, there are disclosed various devices and procedures to facilitate cardiac valve surgery on a beating heart. An important part of any such system is a safe technique for establishing direct intracardiovascular access to the heart, cardiac valves, and the so-called great vessels. Such access must allow the safe introduction of instruments into the cardiovascular system, prevent entry of air into the cardiovascular system, and prevent excessive bleeding. In this respect it should be appreciated that it is generally essential to avoid the introduction of air into the vascular system of the patient, since this could result in serious complications, or even death, for the patient. Another important part of the invention is to enable the simplified opening and closure of incisions into the cardiovascular system.